Tolerance of Early Postoperative Mobilization and Ambulation (MOBTOL)

Tolerance of Early Mobilization and Ambulation the Day of Colorectal and Bariatric Surgery in an Enhanced Recovery Program

Enhanced recovery programme (ERP) includes early postoperative mobilization and ambulation the day of surgery. Data suggest that orthostatic symptoms prevent a large number of patients from ambulating the day of surgery. The investigators plan to include 50 patients scheduled for colorectal surgery and bariatric surgery in an ERP. A 6-min walk test (6MWT) will be performed before surgery, 3 hour after the end of surgery, and 24 hour after surgery. The day of surgery a 2-min walk test will be realized.

Study Overview

• Status: Completed
• Conditions: Colorectal Surgery; Bariatric Surgery; Ambulation Difficulty
• Intervention / Treatment: Behavioral: mobilization and ambulation

Detailed Description

Enhanced recovery programme (ERP) includes early postoperative mobilization and ambulation the day of surgery. Data suggest that orthostatic symptoms prevent a large number of patients (up to 50%) from ambulating the day of surgery.

The investigators plan to include 50 patients scheduled for colorectal surgery and bariatric surgery in an ERP.

The primary endpoint will be the ability to get out of the bed and sit in an armchair. Orthostatic symptom will be recorded. The secondary endpoint will be a 6-min walk test (6-MWT). This test will be performed before surgery, 3 hour after the end of surgery, and 24 hour after surgery. The day of surgery a 2-min walk test (2-MWT) will be realized.

Correlation of the ability to early ambulate and postoperative course (adherence to ERP, complications) will be analyzed.

• Study Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • CHU Liege
  • Liège, Belgium, 4000
    • CHU Liege,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for colorectal or bariatric surgery within an ERP

Description

Inclusion Criteria:

Patients scheduled for colorectal or bariatric surgery within an ERP

Exclusion Criteria:

Patient refusal to participate, inability to walk or stand up.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
colorectal surgery; 50 consecutive patients scheduled to colorectal surgery in an enhanced recovery programme	Behavioral: mobilization and ambulation; 6-min walk test (6-MWT)
bariatric surgery; 50 consecutive patients scheduled to bariatric surgery (gastric by-pass, sleeve gastrectomy) in an enhanced recovery programme	Behavioral: mobilization and ambulation; 6-min walk test (6-MWT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with orthostatic intolerance	orthostatic intolerance is defined as the occurrence of one of the following symptom when the patient stands up : presyncope, dizziness, nausea-vomiting, feeling of heat and blurred vision	24 hour after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-min walk test	This test measures the distance covered during 6-min at normal speed	24 hour after surgery

Collaborators and Investigators

• Sponsor: University of Liege
• Investigators: Principal Investigator: Jean L Joris, MD, Centre Hospitalier Universitaire de Liège

Publications and helpful links

General Publications

• Eriksen JR, Munk-Madsen P, Kehlet H, Gogenur I. Orthostatic intolerance in enhanced recovery laparoscopic colorectal resection. Acta Anaesthesiol Scand. 2019 Feb;63(2):171-177. doi: 10.1111/aas.13238. Epub 2018 Aug 10.
• Hanada M, Tawara Y, Miyazaki T, Sato S, Morimoto Y, Oikawa M, Niwa H, Eishi K, Nagayasu T, Eguchi S, Kozu R. Incidence of orthostatic hypotension and cardiovascular response to postoperative early mobilization in patients undergoing cardiothoracic and abdominal surgery. BMC Surg. 2017 Nov 28;17(1):111. doi: 10.1186/s12893-017-0314-y.
• Skarin MU, Rice DA, McNair PJ, Kluger MT. Orthostatic intolerance following hip arthroplasty: incidence, risk factors and effect on length of stay: A prospective cohort study. Eur J Anaesthesiol. 2019 Feb;36(2):123-129. doi: 10.1097/EJA.0000000000000940.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2019
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 13, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mobility Limitation
• Other Study ID Numbers: 2019/MOBTOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No